PMA P040044S079

Device
Mynx Control Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S079
Product code
MGB
Decision date
2018-09-10
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Approval for modifications to the delivery system handle and changes to the delivery system component materials.

Current openFDA PMA Record#

Device
Mynx Control Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S079
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2018-09-10
Decision code
APPR
Date received
2018-02-05
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for modifications to the delivery system handle and changes to the delivery system component materials.